A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy

Inclusion criteria

• Adult patient, >/= 18 years of age
• Type 2 diabetes mellitus treated with stable metformin monotherapy for at least 12 weeks prior to screening; metformin dose should be >/= 1500 mg/day (or individual maximum tolerated dose), but no more than the maximum dose specified in the label
• HbA1c >/= 7% and </= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
• Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit
• Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study

Exclusion criteria

• Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
• Diagnosis or history of:

• Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
• Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
• Any previous treatment with thiazolidinedione or with a dual PPAR agonist
• Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy
• Prior intolerance to fibrate
• Treatment with anti-diabetic medication other than metformin in the last 12 weeks prior to screening
• Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening
• Clinically apparent liver disease
• Anemia at or within 4 weeks prior to screening
• Inadequate renal function
• Symptomatic congestive heart failure NYHA Class II-IV at screening
• Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
• Known macular edema at screening or prior to screening visit
• Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
• Uncontrolled hypertension
• History of active substance abuse (including alcohol) within the past 2 years